The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0317-2018·Announced 2018-01-17

Repro-Med Systems Recalls Freedom60 Precision Flow Rate Tubing Sets

Repro-Med Systems is recalling Freedom60 Precision Flow Rate Tubing Sets and related needle sets because gaps were found in the sterile barrier packaging during inspection.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a compromised sterile barrier, which poses a risk of infection (harm) to patients. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).

Plain-English summary

Repro-Med Systems, Inc. is recalling Freedom60 Precision Flow Rate Tubing Sets (REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200, F180) and RMS High-Flo Subcutaneous Safety Needle Sets. The recall was initiated after the firm discovered gaps in the sterile barrier packaging during post-sterilization inspection. Specifically, 701 out of 3,195 units of Part Number F180, Lot 1.042/16, were rejected due to a visual defect in the manufacturing seal.

The firm determined that the issue extended beyond the single lot identified and expanded the recall to include other lots of the affected tubing and needle sets. The affected lots include 1.053/16, 1.052/16, 1.051/16, 1.050/16, 1.049/16, 1.048/16, 1.047/16, 1.042/16, 1.041/16, 1.040/16, 1.039/16, 1.038/16, 1.037/16, 1.036/16, 1.033/16, and 1.030/16, all with an expiration date of 2021-02. The products were distributed nationwide in the US.

The recall was conducted voluntarily by the firm via a Voluntary Medical Device Corrections and Removal Notification to customers on March 10, 2016. The source text notes that the recall was conducted without FDA notification at the time. Users should stop using the affected products and contact the manufacturer for further instructions.

The recalled product

Product
Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
Manufacturer
Repro-Med Systems, Inc.
Category
Medical Device — Infusion/Flow Rate Tubing
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • Lot Numbers: 1.053/16
  • 1.052/16
  • 1.051/16
  • 1.050/16
  • 1.049/16
  • 1.048/16
  • 1.047/16
  • 1.042/16
  • 1.041/16
  • 1.040/16
  • 1.039/16
  • 1.038/16
  • 1.037/16
  • 1.036/16
  • 1.033/16
  • & 1.030/16 Expiration: 2021-02

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Repro-Med Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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